Sr. Scientist, Biologics Analytical Development

Johnson Johnson; Malvern (Chester County); On-site; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson in Malvern, PA, is seeking a Sr. Scientist in Biologics Analytical Development to lead development, validation, and transfer of separation assays for protein biotherapeutics.

The role supports programs from early clinical development through commercialization, across monoclonal antibodies, bispecifics, and ADCs. The candidate will lead analytical projects, collaborate with cross-functional teams, and drive improvements in methods, processes, and GMP compliance.

Qualifications

• PhD in Biochemistry or related field with 2+ years pharma/biotech or post-doc, or MS with 5+ years pharma/biotech.
• Strong analytical and problem-solving skills; ability to deliver creative solutions.
• Hands-on experience with protein isolation and separation techniques (electrophoresis, chromatography).
• Excellent organizational, communication, presentation, and scientific writing skills are required.
• Ability to lead across functions and collaborate in a dynamic environment.

Responsibilities

• Develop, validate, and transfer biochemical methods (capillary electrophoresis, HPLC) for biopharmaceutical products.
• Serve as analytical SME for method development, investigations and regulatory inspections.
• Lead analytical projects and collaborate with cross-functional teams from early development to commercialization.
• Provide analytical expertise to support programs across development and manufacturing.
• Drive continuous improvement of analytical methods and lab practices.
• Analyze complex data and present findings to technical and non-technical stakeholders.
• Prepare and review methods, validation/transfer protocols, and regulatory submissions.

Skills

Biochemistry

Analytical thinking

Problem solving

Leadership

Communication

Scientific writing

Team collaboration

Education

Ph.D. in Biochemistry

MS with pharma/biotech experience

BS with 12+ years experience

Tools

Capillary electrophoresis

HPLC

Protein purification

Regulatory documentation tools

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

Scientific/Technology

All Job Posting Locations:

Malvern, Pennsylvania, United States of America

Job Description:

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Sr. Scientist, Biologics Analytical Development.

Purpose:

Therapeutics, Development, and Supply (TDS), Proteins Analytical Development (AD) group is seeking a Sr. Scientist to support our dynamic Analytical Development (AD) Separation Sciences team. The experienced and motivated Senior Scientist will be responsible for development, validation, and transfer of separation assays for protein biotherapeutics including but not limited to monoclonal antibodies, bi- and tri-specific antibodies and antibody drug conjugates to be used in support of clinical and commercial development. You will work and grow in an environment that values innovation, leadership, scientific excellence, urgency, and personal accountability.

You will be responsible for:

• Develop, validate, and transfer biochemical methods, including capillary electrophoresis and HPLC, for the characterization and quality control of biopharmaceutical products
• Serve as the analytical subject matter expert for method development, investigations, and regulatory inspections
• Identify, evaluate, and implement innovative technologies and approaches to address emerging analytical challenges associated with new modalities
• Lead one or more analytical projects and collaborate with analytical integrators and cross-functional partners, including process development and QC scientists, to support programs from early clinical development through commercialization
• Provide analytical expertise to support programs across early- and late-stage clinical development and commercial manufacturing
• Lead continuous improvement initiatives that enhance analytical methods, processes, and laboratory practices
• Analyze complex data sets and communicate findings clearly and concisely to technical and nontechnical stakeholders
• Author, review, and approve analytical methods, validation and transfer protocols, technical reports, and standard operating procedures; present data to peers and functional leadership
• Author and review sections of regulatory submissions, including INDs, IMPDs, and BLAs, and respond to health authority inquiries
• Contribute to laboratory operational improvements that increase efficiency and maintain compliance with Good Manufacturing Practices (GMP)

Qualifications/Requirements:

Education Required:

Ph. D. in Biochemistry or a related scientific field with 2+ years of Pharma/biotech industry or post-doctoral experience OR a Master's degree with 5+ years of Pharma/biotech industry experience OR Bachelor's degree with 12+ years Pharma/biotech industry experience.

Experience and Skills:

Required:

• A strong foundation in biochemistry is required.
• Strong analytical and problem-solving skills, with the ability to develop creative solutions and achieve project objectives, are required.
• Demonstrated scientific expertise and extensive hands-on experience with protein isolation and separation techniques, including electrophoresis and chromatography, are required.
• Excellent organizational, communication, presentation, and scientific and technical writing skills are required.
• Excellent leadership, interpersonal, and negotiation skills, with the ability to work effectively in a dynamic environment and collaborate across functions, are required.

Preferred:

• Knowledge of method robustness, design of experiments (DoE), method design, and assay validation parameters is preferred.
• In-depth experience in large-molecule analytical development, with an emphasis on separation m